Nazione: Canada
Lingua: inglese
Fonte: Health Canada
PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE)
SANDOZ CANADA INCORPORATED
A02BC02
PANTOPRAZOLE
20MG
TABLET (DELAYED-RELEASE)
PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE) 20MG
ORAL
100
Prescription
PROTON-PUMP INHIBITORS
Active ingredient group (AIG) number: 0133229002; AHFS:
APPROVED
2008-06-03
_Sandoz Pantoprazole (pantoprazole sodium sesquihydrate) _ _Page 1 of 53 _ _ _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR SANDOZ PANTOPRAZOLE Pantoprazole Sodium Sesquihydrate Delayed-Release tablets, 20 mg, 40 mg, Oral Proton Pump Inhibitor Sandoz Canada Inc. 110 Rue de Lauzon Boucherville, QC J4B 1E6 Date of Initial Authorization: June 3, 2008 Date of Revision: September 27, 2023 Submission Control Number: 275889 _Sandoz Pantoprazole (pantoprazole sodium sesquihydrate) _ _Page 2 of 53 _ _ _ RECENT MAJOR LABEL CHANGES 7 Warnings and Precautions, Endocrine and Metabolism 03/2021 1 Indications 10/2022 4.2 Recommended Dose and Dosage Adjustment 10/2022 7 Warnings and Precautions, General 10/2022 7 Warnings and Precautions, Hepatic/Biliary/Pancreatic & Renal 10/2022 7 Warnings and Precautions, Immune 09/2023 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. RECENT MAJOR LABEL CHANGES ............................................................................................. 2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ....................................................................... 5 1 INDICATIONS .................................................................................................................... 5 1.1 Pediatrics ................................................................................................................... 5 1.2 Geriatrics ................................................................................................................... 5 2 CONTRAINDICATIONS ...................................................................................................... 5 4 DOSAGE AND ADMINISTRATION ...................................................................................... 6 4.1 Dosing Considerations ................................................................. Leggi il documento completo